Surgeons who conducted clinical trials funded by Medtronic Inc. to test one of the company’s spine-surgery drugs didn’t report serious complications that arose in those trials in their research papers, according to reports.
The study, published on Wednesday in Spine Journal, revealed that serious complications, including cancer, sterility, infections and bone dissolution occurred in 10 percent to 50 percent of patients who were administered Infuse or a sister product in 13 trials conducted between 2000 and 2010.
The complications with the drug, used to spur bone growth, weren’t reported in the papers the surgeons wrote on those trials, though some of the complications are mentioned on the product’s label.
The incomplete reports suggest that the surgeons may have been financially influenced by Medtronic. Fifteen of the surgeons have collectively received at least $62 million from the medical-device company for unrelated work over the past decade, according to a Wall Street Journal analysis of Medtronic documents published late Tuesday.
In advance of the medical journal article, Chief Executive Omar Ishrak defended the data that his company submitted to federal, saying they were sound and support the product’s safe use.
Medtronic, based in Minneapolis, has an insulin pump division in the San Fernando Valley acquired from billionaire Alfred Mann. The spinal operations are based in Nashville.